Renal ImpairmentPhase 1NCT06295796

A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)

A Phase 1 study testing MK-8527 in people with Renal Impairment, run by Merck Sharp & Dohme LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment
What is being tested?: MK-8527
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 20 Jun 2024to 31 Jan 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

The main inclusion criteria include but are not limited to the following:
Moderate and Severe RI
With the exception of RI, is in sufficient health for study participation.
Has stable renal function.
Healthy
Matches mean age to participants with moderate and severe RI.
Has normal renal function.

Who cannot join

The main exclusion criteria include but are not limited to the following:
All participants
History of cancer (malignancy).
Positive test results for Human-immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV).
Had a major surgery or lost significant volume of blood within 56 days prior to dosing.
Donated plasma within 7 days prior to dosing.

Show all 11Show fewer

Moderate and Severe RI
Failed renal transplant or had a nephrectomy.
End stage renal disease requiring dialysis.
Any significant arrhythmia or conduction abnormality.
Has non-sustained or sustained ventricular tachycardia.

Trial locations and contacts

1 site in 1 country.

United States1 site

Research by Design ( Site 0001)
Chicago, Illinois, 60643

Other trials in United States

About this study

Official title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-8527 in Participants With Moderate and Severe Renal Impairment

Conditions: Renal Impairment
Being tested: MK-8527
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-8527Drug
Oral Capsule

Study groups in NCT06295796
Study group	Role	What they receive
Moderate Renal Impairment	Experimental	Participants with moderate renal impairment receive a single dose of MK-8527 on Day 1. Receives: Drug: MK-8527
Severe Renal Impairment	Experimental	Participants with severe renal impairment receive a single dose of MK-8527 on Day 1. Receives: Drug: MK-8527
Healthy	Experimental	Healthy participants receive a single dose of MK-8527 on Day 1. Receives: Drug: MK-8527

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration Versus Time Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-8527 in Plasma
Blood samples were collected at pre-specified time points to determine the AUC0-last of MK-8527 in participant's plasma. AUC0 to last of MK-8527 was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable (above lower limit of quantitation) concentration. AUC0-last was calculated using noncompartmental analysis.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma
Blood samples were collected at pre-specified time points to determine the AUC0-inf of MK-8527 in participant's plasma. AUC0-inf was defined as AUC0-last + (Cest,last/λz) where Cest,last was the estimated last measurable concentration, and λz was the apparent first-order terminal elimination rate constant.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
Maximum Concentration (Cmax) of MK-8527 in Plasma
Blood samples were collected at pre-specified time points to determine the Cmax of MK-8527 in participant's plasma. Cmax was defined as the maximum observed concentration of MK-8527 in plasma after the administration of a given dose.
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
Time to Maximum Concentration (Tmax) of MK-8527 in Plasma
Blood samples were collected at pre-specified time points to determine the tmax of MK-8527 in participant's plasma. Tmax of MK-8527 in plasma was determined by deriving the difference between the time of the blood draw associated with the Cmax and the time of study drug administration
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma
Blood samples were collected at pre-specified time points to determine the t1/2 of MK-8527 in participant's plasma. t1/2 was defined as 0.693/Apparent terminal elimination rate constant (λz).
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
Apparent Clearance (CL/F) of MK-8527 in Plasma
Blood samples were collected at pre-specified time points to determine the CL/F of MK-8527 in participant's plasma. CL/F was defined as dose/(AUC0-inf).
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527 in Plasma
Blood samples were collected at pre-specified time points to determine the Vz/F of MK-8527 in participant's plasma. Vz/F of MK-8527 in plasma was determined using the formula Dose/(AUC0-inf × λz).
Measured: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose

Secondary outcomes (10)

Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 29 days
Number of Participants Who Discontinue Study Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to approximately 29 days
AUC0-last of MK-8527-triphosphate (TP) in Peripheral Blood Mononuclear Cells (PBMCs)
Blood samples were collected at pre-specified time points to determine the AUC0-last of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. AUC0 to last of MK-8527 was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable (above lower limit of quantitation) concentration.
Measured: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
AUC0-inf of MK-8527-TP in PBMCs
Blood samples were collected at pre-specified time points to determine the AUC0-inf of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. AUC0-inf was defined as AUC0-last + (Cest,last/λz) where Cest,last was the estimated last measurable concentration, and λz was the apparent first-order terminal elimination rate constant.
Measured: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
Cmax of MK-8527-TP in PBMCs
Blood samples were collected at pre-specified time points to determine the Cmax of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Cmax was defined as the maximum observed concentration of MK-8527-TP after the administration of a given dose.
Measured: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
Concentration at 168 Hours (C168) of MK-8527-TP in PBMCs
Blood samples were collected at pre-specified time points to determine the C168 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Geometric mean of C168 of MK-8527-TP in PBMCs was determined.
Measured: 168 hours post dose
Concentration at 672 Hours (C672) of MK-8527-TP in PBMCs in Participants With Moderate and Severe Renal Impairment
Blood samples were collected at pre-specified time points to determine the C672 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Geometric mean of C672 of MK-8527-TP in PBMCs was determined.
Measured: 672 hours post dose
C672 of MK-8527-TP in PBMCs in Healthy Participants
Blood samples were collected at pre-specified time points to determine the C672 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Since ≤ 50% of healthy participants had BLQ values, the BLQ value was set to zero and the median, minimum, and maximum was reported for C672.
Measured: 672 hours post dose
Tmax of MK-8527-TP in PBMCs
Blood samples were collected at pre-specified time points to determine the Tmax of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. Tmax of MK-8527-TP was determined by deriving the difference between the time of the blood draw associated with the Cmax and the time of study drug administration
Measured: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
T1/2 of MK-8527-TP in PBMCs
Blood samples were collected at pre-specified time points to determine the t1/2 of MK-8527-TP, the active triphosphate anabolite of MK-8527, in participant's PBMCs. t1/2 was defined as 0.693/Apparent terminal elimination rate constant (λz).
Measured: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 202431 Jan 2025

First posted6 Mar 2024
Study start20 Jun 2024
Primary completion31 Jan 2025
Study completion31 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Renal ImpairmentStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06295796
Sponsor's protocol ID: 8527-008
Other IDs: MK-8527-008
Status last verified: Jan 2026
First submitted: 29 Feb 2024
Last updated: 17 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-8527 in Participants With Moderate and Severe Renal Impairment
ClinicalTrials.gov ID: NCT06295796
Acronym / sponsor ID: 8527-008
Conditions: Renal Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 20 Jun 2024 (actual)
Primary completion: 31 Jan 2025 (actual)
Study completion: 31 Jan 2025 (actual)
First posted: 6 Mar 2024 (actual)
Results: Posted 17 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Moderate Renal Impairment	Experimental	Drug: MK-8527Participants with moderate renal impairment receive a single dose of MK-8527 on Day 1.
Severe Renal Impairment	Experimental	Drug: MK-8527Participants with severe renal impairment receive a single dose of MK-8527 on Day 1.
Healthy	Experimental	Drug: MK-8527Healthy participants receive a single dose of MK-8527 on Day 1.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Moderate and Severe RI
With the exception of RI, is in sufficient health for study participation.
Has stable renal function.
Healthy
Matches mean age to participants with moderate and severe RI.

Key exclusion criteria (11 listed)

All participants
History of cancer (malignancy).
Positive test results for Human-immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV).
Had a major surgery or lost significant volume of blood within 56 days prior to dosing.
Donated plasma within 7 days prior to dosing.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-8527Oral Capsule	Drug	Healthy, Moderate Renal Impairment, Severe Renal Impairment

Primary outcome

Area Under the Concentration Versus Time Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-8527 in Plasma
Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
Blood samples were collected at pre-specified time points to determine the AUC0-last of MK-8527 in participant's plasma. AUC0 to last of MK-8527 was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable (above lower limit of quantitation) concentration. AUC0-last was calculated using noncompartmental analysis.
Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma
Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
Blood samples were collected at pre-specified time points to determine the AUC0-inf of MK-8527 in participant's plasma. AUC0-inf was defined as AUC0-last + (Cest,last/λz) where Cest,last was the estimated last measurable concentration, and λz was the apparent first-order terminal elimination rate constant.
Maximum Concentration (Cmax) of MK-8527 in Plasma
Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
Blood samples were collected at pre-specified time points to determine the Cmax of MK-8527 in participant's plasma. Cmax was defined as the maximum observed concentration of MK-8527 in plasma after the administration of a given dose.
Time to Maximum Concentration (Tmax) of MK-8527 in Plasma
Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
Blood samples were collected at pre-specified time points to determine the tmax of MK-8527 in participant's plasma. Tmax of MK-8527 in plasma was determined by deriving the difference between the time of the blood draw associated with the Cmax and the time of study drug administration
Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma
Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
Blood samples were collected at pre-specified time points to determine the t1/2 of MK-8527 in participant's plasma. t1/2 was defined as 0.693/Apparent terminal elimination rate constant (λz).
Apparent Clearance (CL/F) of MK-8527 in Plasma
Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
Blood samples were collected at pre-specified time points to determine the CL/F of MK-8527 in participant's plasma. CL/F was defined as dose/(AUC0-inf).
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527 in Plasma
Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose
Blood samples were collected at pre-specified time points to determine the Vz/F of MK-8527 in participant's plasma. Vz/F of MK-8527 in plasma was determined using the formula Dose/(AUC0-inf × λz).

10 secondary outcomes

Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 29 days
Number of Participants Who Discontinue Study Due to an AE
Time frame: Up to approximately 29 days
AUC0-last of MK-8527-triphosphate (TP) in Peripheral Blood Mononuclear Cells (PBMCs)
Time frame: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
AUC0-inf of MK-8527-TP in PBMCs
Time frame: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
Cmax of MK-8527-TP in PBMCs
Time frame: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
Concentration at 168 Hours (C168) of MK-8527-TP in PBMCs
Time frame: 168 hours post dose
Concentration at 672 Hours (C672) of MK-8527-TP in PBMCs in Participants With Moderate and Severe Renal Impairment
Time frame: 672 hours post dose
C672 of MK-8527-TP in PBMCs in Healthy Participants
Time frame: 672 hours post dose
Tmax of MK-8527-TP in PBMCs
Time frame: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose
T1/2 of MK-8527-TP in PBMCs
Time frame: Predose, 4, 12, 24, 48, 96, 120, 144, 168, 336, 504, 672 hours post dose

Results and safety

Results posted to the registry on 17 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy	6	6
Moderate Renal Impairment	6	6
Severe Renal Impairment	6	6

Primary outcome: Area Under the Concentration Versus Time Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-8527 in Plasma

Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: nM·hr

Measure	Healthy n = 6	Moderate Renal Impairment n = 6	Severe Renal Impairment n = 6
Value	769 (21.4)	1160 (24.6)	1430 (20.1)

Healthy vs Moderate Renal Impairment: Geometric Mean Ratio (GMR): 1.51 (90% CI 1.19 to 1.92)
Healthy vs Severe Renal Impairment: Geometric Mean Ratio (GMR): 1.86 (90% CI 1.50 to 2.31)

Population analysed: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model

Primary outcome: Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma

Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: nM·hr

Measure	Healthy n = 6	Moderate Renal Impairment n = 6	Severe Renal Impairment n = 6
Value	918 (22.2)	1640 (30.0)	2060 (24.0)

Healthy vs Moderate Renal Impairment: Geometric Mean Ratio (GMR): 1.79 (90% CI 1.36 to 2.36)
Healthy vs Severe Renal Impairment: Geometric Mean Ratio (GMR): 2.24 (90% CI 1.77 to 2.85)

Population analysed: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.

Primary outcome: Maximum Concentration (Cmax) of MK-8527 in Plasma

Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: nM

Measure	Healthy n = 6	Moderate Renal Impairment n = 6	Severe Renal Impairment n = 6
Value	112 (25.7)	161 (48.9)	91.7 (22.1)

Healthy vs Moderate Renal Impairment: Geometric Mean Ratio (GMR): 1.43 (90% CI 0.96 to 2.14)
Healthy vs Severe Renal Impairment: Geometric Mean Ratio (GMR): 0.82 (90% CI 0.64 to 1.05)

Primary outcome: Time to Maximum Concentration (Tmax) of MK-8527 in Plasma

Time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose. Median (Full Range). Unit: hr

Measure	Healthy n = 6	Moderate Renal Impairment n = 6	Severe Renal Impairment n = 6
Value	0.75 (0.52 to 1.53)	0.75 (0.50 to 1.00)	0.99 (0.25 to 6.00)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to approximately 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moderate Renal Impairment	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Severe Renal Impairment	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Healthy	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Merck Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-8527 in people with Renal Impairment, run by Merck Sharp & Dohme LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration Versus Time Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-8527 in Plasma (time frame: Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06295796.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.